The Recall Desk
ModerateFDA (Devices)·Z-2625-2016·Announced 2016-08-31

Siemens CT Scanner Recall Due to Contrast Injection Failure

Siemens is recalling two CT scanners where a software error prevents contrast agent injection during automatic scans, resulting in failed examinations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a functional failure resulting in a missed diagnosis rather than direct physical injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling two SOMATOM Definition Flash computed tomography (CT) x-ray systems (Model # 10590000) equipped with software version VA48A-SP2. The affected units have serial numbers 83398 and 83387. These systems were distributed to facilities in Michigan, New York, California, Kentucky, North Dakota, and Nebraska.

The recall is due to an internal communication error between the firmware and software components. This error causes the CT scan to execute properly, but the contrast agent injector is not started in automatic or coupled modes. Consequently, the contrast agent is not injected, and the desired examination result is not achieved. The issue does not affect the manual control of the injector.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for a software update or repair to resolve the communication error. Patients who underwent scans on these devices during the affected period may need to repeat the examination to obtain the necessary diagnostic results.

The recalled product

Product
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model # 10590000 Serial # 83398
  • and 83387

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · software error

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